Pouch with mounting member for removable adhesive filter

ABSTRACT

An annular mounting member is bonded to the pouch wall to define a vent opening. The mounting member is made of material which is compatible with the pouch film and has a smooth exterior surface adapted to facilitate removable mounting of an adhesive coated element in alignment with the opening. The element may be a deodorizing filter assembly including a filter disk surrounded by an annular border member coated with pressure sensitive adhesive or a gas impermeable cover member designed to close the vent.

This is a divisional of co-pending application Ser. No. 367,237, filedon Jun. 16, 1989, now U.S. Pat. No. 5,085,652.

The present invention relates to medical devices of the type includingcollection receptacles with deodorizing filters and more particularlywith a medical device which includes a collection receptacle or pouchhaving a mounting member bonded thereto and adapted to facilitateremovable mounting of a deodorizing filter assembly or cover element.

BACKGROUND OF THE INVENTION

Certain surgical procedures, such as colostomies, ileostomies orurostomies result in a surgically created opening or stoma in theabdominal wall through which bodily wastes are discharged. Because thepatient has no control over the discharge, an appliance is utilizedwhich includes a collection receptacle in the form of a pouch or bagwhich is affixed to the patient in alignment with the stoma. Theappliance collects waste as it is discharged and also protects thestoma.

Other medical procedures, such as wound care or irrigation, also utilizedevices which include a collection receptacle. Such receptacles may bein the form of a pouch or bag as well.

Such collection pouches or bags are often formed of thin sheets ofmaterial welded along the periphery. The materials are generallycomposed of light weight, odor proof, flexible polymeric plastic.

Because a portion of the material to be collected is often gaseous, aproblem arises with respect to the distention of the pouch due to theaccumulation of gas, a great disadvantage in an ostomy system, forexample, which is designed to be inconspicuous and permit the ostomateto engage in normal physical activity without embarrassment. To overcomethe problem of accumulated gases, many devices utilize a configurationwhich permits venting of the gas. However, the venting of gases oftenpresents a problem with respect to odor. In order to eliminate odor asthe gas is vented, deodorizing filters have been employed.

The gas venting problem has been subjected to a variety of differentsolutions. Some pouches have been provided with a tortuous path ventopening, with or without a deodorizing filter. Others have been providedwith openings in the pouch wall, covered with deodorizing filters.Another approach has been to provide replaceable filters attached to thebag by a series of plural sequentially peelable adhesive members.

Certain ostomy systems, such as that disclosed in U.S. Pat. No.4,460,363 to Steer et al., permit pouches to be removed and reused,hence prolonging the useful life of the pouch beyond the useful life ofa single filter. It is therefore often necessary that the deodorizingfilter itself be replaced periodically in order to insure that completedeodorization is taking place. On the other hand, it may be desirable,in certain instances, to eliminate the deodorizing filter completely,and simply seal the vent. Accordingly, it is most desirable to have astructure where the filter can be removed as necessary so that it can bereplaced or the vent can be obstructed. The use of adhesive coatedelements is particularly well adopted for this purpose.

Prior art pouches adapted for use with filters either have had thefilters permanently bonded to the pouch wall, such as by heat or impulsewelding or, if removable filter mounting is employed, the filter isadhesively mounted directly to the pouch wall surrounding the ventopening. However, the pouch wall is made of a material which, in thelatter case, does not permit an adhesive element to be easily removedand replaced. Because the pouch wall is so thin, an adhesive strongenough to make the required seal will often cause the wall to teararound the vent opening as the filter is removed, clearly a severedisadvantage. In addition, the pouch wall is so thin surrounding thevent opening that it tends to wrinkle, preventing a good seal withadhesive coated filter.

OBJECTS OF THE INVENTION

To overcome the above difficulties, a pouch has been designed with amounting member permanently affixed to the pouch wall surrounding thevent opening. The mounting member is made of a material which iscompatible with the pouch film such that it can be permanently bondedthereto. It has an exterior surface which is adapted to facilitatesealing engagement with an adhesive coated element, which may be afilter assembly or a cover element. The mounting member serves toincrease the effectiveness of the adhesive seal by providing awrinkle-free mounting surface compatible with the adhesive and at thesame time prevent the pouch wall from being torn along the vent openingas the adhesive element is removed therefrom.

It is, therefore, a prime object of the present invention to provide apouch with a mounting surface for a removable adhesive filter assembly.

It is another object of the present invention to provide a pouch with amounting member which is made of material which is compatible with thematerial of the pouch wall.

It is another object of the present invention to provide a pouch with amounting member which has an annular configuration and is affixed to thepouch wall surrounding the vent opening.

It is another object of the present invention to provide a pouch with amounting member for an adhesive filter of the type which permits gaseousflow in a direction perpendicular to its surface.

It is another object of the present invention to provide a pouch with amounting member for an adhesive filter assembly of the type whichincludes a filter disk surrounded by a border member coated withadhesive.

It is another object of the present invention to provide a pouch with amounting member which permits a cover member to be affixed thereto whenthe filter is absent.

In accordance with one aspect of the present invention, a device isprovided comprising a collection receptacle in the form of a thin walledpouch. The pouch comprises a vent through which gaseous matter mayescape. A mounting member is affixed to the pouch wall, surrounding thevent. The member has an opening aligned with the vent such that thepassage of gases through the vent is substantially unobstructed. Themember has an exterior surface adapted to facilitate removable mountingof an adhesive element in alignment with the vent.

The mounting member is composed of a material which is compatible withthe material of the pouch wall. Preferably the mounting member iscomposed of a mixture of polyethylene and ethylene vinyl acetate.Preferably, it is annular in configuration.

The removable element may be in the form of gas impermeable coverelement coated with a pressure sensitive adhesive. Preferably, the coverelement has a substantially circular configuration with a radiallyextending tab.

Alternatively, the removable element may comprise a filter assemblyincluding a filter disk and a means for encapsuling the filter disk. Thefilter disk may comprise an open cell foam treated with activatedcarbon. The encapsulating means may comprise thin sheets of microporousfilm between which the filter disk is sandwiched. The films preferablyhave a bonded edge and are preferably treated to be liquid impervious.

A substantially annular border member is provided as part of theassembly. The border member is composed of a closed cell foam. It ispreferably coplanar with and surrounds the filter disk. Preferably, theborder member is coated with a pressure sensitive adhesive layer. Anexterior film layer may be provided with an opening. The exterior layeris bonded to the filter disk and the border member.

In accordance with another aspect of the present invention, a device isprovided including a collection receptacle in the form a thin walledpouch. The pouch has a vent through which gaseous matter may escape. Amounting member is affixed to the pouch wall surrounding the vent. Themember has an opening aligned with the vent such that passage of gasesthrough the vent is substantially unobstructed. The member is adapted topermit removable mounting of an adhesive coated filter element inalignment with the opening such that gases are filtered through theelement as they pass from the pouch.

In accordance with another aspect of the present invention, a device isprovided comprising a collection receptacle in the form of a thin walledpouch. The pouch includes a vent through which gaseous matter mayescape. A mounting member is affixed to the pouch wall surrounding thevent. The member has an opening aligned with the vent such that thepassage of gases through the vent is substantially unobstructed. Themounting member is adapted to permit removable mounting of a coverelement over the opening such that gases are prevented from escapingthrough the vent.

In accordance with another aspect of the present invention, a devicecomprising a collection receptacle in the form of a thin walled pouch isprovided in combination with a member affixed to the wall of the pouchand punch means for creating a vent through the member and wall. Themember, once punched, defines a boarder surrounding the vent adapted tofacilitate removable mounting of a filter assembly in alignment with thevent.

The punch means preferably comprises first and second hingeablyconnected parts. A protrusion extends from one of the parts. A recess isformed in the other of the parts. The protrusion and the recess areadapted to align with the member therebetween.

Means are provided for adhesively mounting the filter assembly to themember. The filter assembly preferably comprises a filter disk,microporous film for encapsulating the disk and an annular bordermember. Preferably the border member is coated with an adhesive.

BRIEF DESCRIPTION OF THE DRAWINGS

To these and such other objects which may hereinafter appear, thepresent invention relates to an ostomy pouch with a mounting member foran adhesive filter, as set forth in detail in the followingspecification and recited in the annexed claims, taken together with theaccompanying drawings, wherein like numerals refer to like parts, and inwhich:

FIG. 1 is an exploded isometric view of an ostomy pouch including themounting members of the present invention, showing a cover member and afilter element alternately mountable thereon.

FIG. 2 is a plan view of the top portion of the rear of the pouch wallshowing a cover element mounted thereon;

FIG. 3 is a view similar to FIG. 2 but showing the pouch with a filterelement mounted thereon;

FIG. 4 is a cross-sectional view taken along line 4--4 of FIG. 2;

FIG. 5 is a cross-sectional view taken along line 5--5 of FIG. 3;

FIG. 6 is a plan view of the top portion of the rear of a pouch wallillustrating a second preferred embodiment of the present invention;

FIG. 7 is an isometric view of a punch used in conjunction with thepouch illustrated in FIG. 6;

FIG. 8 is a cross-sectional view of the pouch wall illustrated in FIG. 6taken along line 8--8;

FIG. 9 is a cross-sectional view showing the punch of FIG. 7 in the openposition, with a portion of the pouch therein;

FIG. 10 is a view similar to FIG. 9 but showing the punch in the closedposition; and

FIG. 11 is a cross-sectional view similar to that shown in FIG. 8 butillustrating the pouch after the vent has been punched.

DESCRIPTION OF THE INVENTION

As seen in FIGS. 1 through 5, the first preferred embodiment of thepresent invention includes a collection receptacle in the form of apouch, generally designated A. Pouch A includes a rear wall 10 and afront wall 12 made of thin, flexible, preferably transparent, film whichis heat welded around the periphery to form an enclosed receptacle.

Although the pouch A which is illustrated has no outlet, an outlet maybe provided as is conventional. The pouch illustrated in the drawings isof the type utilized in a so-called "two-piece" ostomy appliance; thatis, an appliance in which the pouch is detachably mounted to an adhesivecoated dressing designed to be affixed to the body surrounding thestoma. It should be appreciated that while the present invention isillustrated in conjunction with a detachable pouch of the closedvariety, it is equally applicable to one-piece type appliances whereinthe pouch is permanently affixed to the dressing. The particularconfiguration of the pouch plays no portion in the present inventionwhich is equally applicable to all pouch styles.

The films from which the pouch may be made are selected from materialswhich possess the properties of being moisture impermeable, odorimpermeable and capable of being heat sealed or impulse welded. Suitablematerials include polyethylene, copolymers of polyethylene and ethylenevinyl acetate, copolymers of vinyl chloride and polyvinylidene chlorideand lamanents thereof. The pouch walls are preferably from about 2-4mils thick.

Wall 12 is provided with a stoma receiving opening 14 which is definedby a coupling ring 16 of the type which is conventional in two-pieceostomy devices such as those disclosed in Steer U.S. Pat. No. 4,460,363.

Rear wall 10 is provided with a circular vent 18 which is preferablycentered approximately in alignment with a portion of the coupling ring16. Surrounding vent 18 is a mounting member 20 which is permanentlyaffixed or laminated to the pouch wall surrounding the vent. Member 20preferably has an annular configuration.

Mounting member 20 is made of a material which exhibits superiorcharacteristics when a pressure-sensitive adhesive is applied to it andpeeled from it. The thickness of the mounting member eliminates foldsand wrinkles in the pouch film which prevent a fluid tight seal betweenthe wall and the filter assembly. Stress exerted on the pouch film as afilter is removed is more evenly distributed by the mounting member,preventing tears in the film which otherwise would start adjacent at thevent.

The mounting member preferably comprises a blend of polyethylene andethylene vinyl acetate which is compatible with the pouch film. As bestseen in FIGS. 4 and 5, mounting member 20 comprises a disk 22 affixed tothe outer surface of wall 10 surrounding opening 18.

As illustrated in the drawings, mounting member 20 is adapted to affixeither a filter assembly, generally designated 26 or cover member 28over the vent. It should be appreciated that the vent in member 20 ispreferably relatively large so as not to become obscured by solid orsemi-solid waste.

While a variety of different filter assemblies may be utilized, it ispreferable to use an assembly which permits movement of gas therethroughin a direction substantially perpendicular to its surface. The filterassembly illustrated in the drawings is of the type described in SteerU.S. Pat. No. 4,668,258 and is believed to be preferable for thispurpose. However, the precise structure of the filter assembly plays nopart in the structure of the filter assembly plays no part in thepresent invention and should not be considered a limitation thereto.

As best seen in FIG. 5, the filter assembly preferably comprises a diskof foamed, open cell non-woven synthetic polymeric material, forexample, polyurethane having a large number of activated carbonparticles distributed over its major surface. This foam disk 30 is thenlaminated between two thin sheets of a heat sealable microporous film32, 34, such as polyurethane which is preferred, polyethylene,polyvinylchloride, etc. The surface of sheet 34 which will face thepouch is preferably treated with a water repellant such aspolytetrafluorethylene (PTFE), fluorinated ethylenepropalene (FEP),silicone or wax.

One material which is suitable for use as disk 30 is commerciallyavailable under the trade name BONDINA. Another type of suitabledeodorizing material is a felt pad impregnated with activated charcoalin fine particulate form. Various types of such carbon cloth arecommercially available.

Filter disk 30 is surrounded by an annular border member 36, preferablyfabricated of a closed cell foam with a pressure sensitive adhesivelayer 38. A top film layer 40 with a center hole for gas flow is bondedto the exterior surface of border member 36 and the filter disk.

This construction, including the foam border member 36, makes the filtereasier to handle, apply and remove, particularly for patients with poordexterity. The mass of the foam also keeps the filter assembly flat forwrinkle-free applications.

Accordingly, filter assembly 26 forms a stick-on deodorizing filterparticularly well suited for removing odors from ostomy and wound carepouches. The odors are absorbed as they pass through the open cell foamtreated with activated carbon. The backing of the filter assembly iscoated with a pressure-sensitive adhesive which allows placement overthe vent in the pouch.

When the filter loses its deodorizing abilities, it is simply peeled offand replaced with a new filter assembly. The soft, flexible constructionof the filter conforms to bends in the pouch and the wearer's body,making this device comfortable and inconspicuous under clothing. Thefilter is water-repellent and may be worn while showering or bathing.

In the event that the user does not wish to use a filter, vent 18 can besealed through the use of a simple cover element 28. Cover element 28 ispreferably a thin, gas and liquid impervious plastic disk, coated withan adhesive layer which affixes to disk 22 of the mounting member 20, asillustrated in FIGS. 2 and 4. For convenience, cover element 28 isprovided with an outwardly extending gripping tab 42 which is preferablynot coated with adhesive such that the cover member can be more easilygripped and removed.

The second preferred embodiment of the present invention, as illustratedin FIGS. 6 through 11, includes a pouch A' with a rear wall 10' and afront wall 12' with a coupling ring 16', all of which are virtuallyidentical to that illustrated in FIGS. 1 through 5. In the secondpreferred embodiment, mounting member 20 has been replaced by a circularmounting member 50 which, unlike mounting member 20, has no centralopening. Mounting member 50 is, however, made of the same material asmounting member 20 and is preferably situated at the same location onthe pouch.

As shown in FIG. 8, mounting member 50 comprises a circular disk 52situated on outer surface of pouch wall 10'. As will be appreciated fromFIG. 8, pouch wall 10' has no vent therein when supplied to the patient.

In order to create a vent through mounting member 50 and wall 10' of thepouch, a punch of the type illustrated in FIGS. 7, 9 and 10 is provided.As best seen in FIG. 7, the punch includes first and secondsubstantially planar elements 56, 58 which are hingeably connected bymeans of a living hinge 60. The interior surface of element 56 isprovided with an outwardly extending protrusion 62 preferably having asubstantially tubular configuration with an inclined rim.

Situated on the interior surface of element 58 is an annular member 64defining a recess 66 which, when elements 56 and 58 are situated insubstantially parallel planes, will align with protrusion 62.

As best seen in FIG. 9, in order to punch a vent through wall 10' andmounting member 50, pouch A' is situated between elements 56 and 58 withprotrusion 62 aligned with the inlet opening defined by coupling ring16' on wall 12' and further aligned with mounting member 50. The punchis then closed, as illustrated in FIG. 10, such that protrusion 62 isreceived within opening 66 and a vent 70 is punched in the pouch walland through the mounting member, as illustrated in FIG. 11. It will benoted that when the punch is closed, elements 56 and 58 assume asubstantially parallel position because element 56 has a portion 56awhich is substantially perpendicular to the remainder of element 56 andwhich is connected to portion 58 by means of hinge 60. The length ofsection 56a is approximately equal to the length of protrusion 62 suchthat when the punch is closed the elements are substantially parallel.

After the punch has formed the vent in the pouch wall and the circularmounting member, the pouch will appear substantially as shown in FIGS. 1through 5. It may then be utilized with a filter assembly 26 or covermember 28 precisely as described above.

It will now be appreciated that the present invention relates to a pouchor the like which has a mounting member affixed to its wall which isformed of material which will protect the pouch wall from tearing orwrinkling and at the same time be more compatible with an adhesive tofacilitate use of a removable filter assembly. In a first embodiment,the mounting member is annular, having a vent formed when the pouch isfabricated. In a second preferred embodiment, the pouch is provided witha circular mounting member with no vent therein and a punch which isadapted to be utilized to provide a vent through the mounting member andpouch wall. The pouch of the present invention may be utilized with afilter assembly of conventional structure coated with known adhesives.

While only a limited number of preferred embodiments have been disclosedfor purposes of illustration, it is obvious that many variations andmodifications could be made thereto. It is intended to cover all ofthese variations and modifications which fall within the scope of thepresent invention as defined by the following claims:

We claim:
 1. In combination, an ostomy device comprising a collectionreceptacle in the form of a pouch having first and second walls, one ofsaid walls having a waste receiving opening therethrough, means forfluidically coupling said waste receiving opening to a stoma of apatient, a filter mounting means permanently affixed to the exteriorsurface of the other of said walls in alignment with the waste receivingopening and separate punch means comprising first and second hingeablyconnected elements, one of said elements comprising a protrusion and theother of said portions comprising means for defining a recess to receivesaid protrusion, said punch means for removably receiving a portion ofthe pouch between said elements with said waste receiving opening andsaid, mounting means aligned between said protrusion and said recessdefining means and for removably inserting said protrusion through saidwaste receiving opening and removably punching said protrusion throughsaid mounting means and the other of said walls affixed thereto so thatsaid protrusion is removably received within said recess defining meansand such that a vent is formed through said mounting means and saidother of said walls affixed thereto, said mounting means for removablemounting of a filter over the vent when the portion of the pouch isremoved from said punch means.
 2. The device of claim 1 wherein saidmounting means has a substantially annular configuration.
 3. Thecombination of claim 1 wherein said mounting means is comprised ofpolyethylene and ethylene vinyl acetate.
 4. The combination of claim 1further comprising a filter and means for adhesively affixing saidfilter on said mounting means.
 5. The combination of claim 1 wherein oneof said elements comprises a substantially planar portion and a portionsubstantially perpendicular to said planar portion.
 6. The combinationof claim 5 further comprising a living hinge hingeably connecting saidelements.
 7. The combination of claim 6 wherein said living hinge isadjacent to said perpendicular portion.
 8. The combination of claim 5wherein said protrusion is substantially parallel to said perpendicularportion when said protrusion is received within said recess definingmeans.
 9. The combination of claim 1 further comprising a living hingehingeably connecting said elements.